Drug product
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
D-0053-2018
Product summary
- Event
- Event 78106
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12 bottles
- Official record key
drug-enforcement:D-0053-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Code information: Lot #: 55097-2, 56085-1, Exp 11/30/2018
Distribution pattern: Product was distributed in Florida
Derived failure modes
-
Potency or specification failure
out of specification